CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 2

Question 1

What is the maximum BUD for a Category 2 CSP stored frozen (-25°C to -10°C) when no stability data is available?

Accepted Answer

180 days

Answer

USP <797> permits a BUD of up to 180 days for Category 2 CSPs stored frozen when no product-specific stability data exists.

Question 2

Which of the following is the BEST source to verify the chemical stability of a CSP ingredient before assigning a BUD?

Accepted Answer

Trissel's Handbook on Injectable Drugs

Answer

Trissel's Handbook on Injectable Drugs is a primary peer-reviewed reference for parenteral compatibility and stability data.

Question 3

A compounded IV admixture shows a visible color change after 24 hours of storage. This observation most likely indicates:

Accepted Answer

Chemical degradation or incompatibility

Answer

A color change in a CSP is a physical sign of chemical degradation or drug incompatibility, warranting rejection.

Question 4

Which pH range is generally considered most favorable for the stability of most aqueous injectable CSPs?

Accepted Answer

4.5–8.5

Answer

Most parenteral drugs exhibit optimal stability in the pH range of 4.5–8.5, which also aligns with physiologic tolerability.

Question 5

Under USP <797>, which of the following actions is required when a CSP's BUD has been exceeded?

Accepted Answer

Discard the preparation immediately

Answer

Once a BUD has passed, the CSP must be discarded because its sterility and potency can no longer be assured.

CSPT - Compounded Sterile Preparation Technician Practice Test